A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

• Status: Completed
• Trial end date: 2020-02-13
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fesoterodine; Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

• Subjects aged 6 to 17 years old

• Subjects with stable neurological disease and neurogenic detrusor overactivity

• Subjects using clean intermittent catheterization may participate

Exclusion Criteria:

• Concomitant medications which may increase the risk to subjects or confound study results

• Other medical conditions which may increase the risk to subjects or confound study results

• Contraindications to the use of fesoterodine or oxybutynin